Vyaire Medical has already had a US Food and Drug Administration (FDA)-tagged Class I recall this year, and now the company is in hot water with the agency again – this time for tubes in the company’s cardiopulmonary exercise test (CPET) system.

Vyaire’s Twin Tube sample lines collect gas samples from test subjects using the Vyntus CPX system – a CPET device. The system has sensors that measure oxygen and carbon dioxide from the patient’s inhalations and exhalations to provide lung function data.  Within the tube is a drying hose that protects the gas sensors from moisture in the patient’s inhalations and exhalations.

The reason for the recall relates to a nozzle separating from the tube and falling into the patient’s mouth. The FDA says this can cause choking and airway obstruction.

A total of 649 devices in the US distributed between January 2015 and June 2023 have been recalled.

While a Class I recall means continued use of a device could result in serious injury or death, Germany-based Vyaire has reported no injuries or deaths. The company requested customers to identify faulty devices and perform a “pull-out test” to verify the nozzle is attached.

Vyaire did not immediately respond to Medical Device Network for comment.

This is the second Class I recall of the year for Vyaire. In March, the company recalled more than six and a half million manual resuscitators from its AirLife range due to a manufacturing defect. Vyaire initiated the recall following reports of patients not receiving enough ventilation, potentially resulting in hypoventilation or hypoxia. A total of 37 incidents were reported, including two injuries and two deaths.

It’s been a rocky start for the group’s chief executive officer John Bibb who was promoted to the post exactly one year ago. Investment firm Apax Global Alpha, which has Vyaire on its books, said it took a hit in Q1 2024 earnings due to poor performance at the medtech company.